BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRINICA & TRINICA SELECT

    MDR report key: 6001508 · Received October 5, 2016

    Report

    Report Number
    0002184052-2016-00245
    Event Type
    Injury
    Date Received
    October 5, 2016
    Date of Event
    July 18, 2016
    Report Date
    March 27, 2017
    Manufacturer
    ZIMMER SPINE
    Product Code
    KWQ
    PMA / PMN Number
    PK132012
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION. INITIAL REPORT FOUR OF SIX FOR THE SAME EVENT, REFERENCE 0002184052-2016-00242 THROUGH 0002184052-2016-00247. REFERENCE SUPPLEMENTAL REPORTS 0002184052-2016-00195-1, 00196-1, 00197-1, AND 00198-1.

    Additional Manufacturer Narrative · 1

    THE RETURNED SCREWS WERE EXAMINED. THEY WERE MECHANICALLY INSPECTED AND MEASURED, AND FOUND TO MEET SPECIFICATIONS. A REVIEW OF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT. NO FAILURES WERE DETECTED WITH THE SCREWS; THE COMPLAINT COULD NOT BE CONFIRMED FOR THEM.

    Description of Event or Problem · 1

    THE SALES ASSOCIATE REPORTED SCREWS STUCK INSIDE THE 4.2 SELF-DRILLING SCREW CADDIE. ALL OF THE SELF-DRILLING FIXED ANGLE SCREWS ARE MOLDED INTO THE CADDY. THE SCREWS WOULD NOT COME OUT WITH COBB, NEEDLE DRIVER, ETC. THE SURGEON WAS UNABLE TO USE ANY FIXED SCREWS AND FORCED TO USE VARIABLE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652287 TRINICA & TRINICA SELECT SELF-DRILLING SCREW FIXED 4.2X14 KWQ ZIMMER SPINE N/A MFT

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention